Drugs

Court Orders FDA Reconsideration of Brixadi Application

The DC federal court has vacated an FDA 12/2018 exclusivity determination that blocked Braeburn’s Brixadi (buprenorphine) extended-release injection for treating opioid use disorder from final approval through 11/30/20 due to exclusivity granted to Indivior’s Sublocade. The court told FDA to reconsider its decision “with deliberate speed.”

The court said that the agency determined Sublocade exclusivity in the broadest sense and failed to demonstrate how the drug’s exclusivity was consistent with agency previous decisions.

Separately, Braeburn says it continues to wait for an FDA decision on its citizen petition asking that the agency refuse to give orphan drug exclusivity to Sublocade on the basis that opioid use disorder is not a bona fide orphan disease with over two million Americans diagnosed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome